Bolton Medical Inc.: RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-M4-XX-XXX-XXX

Hazard

The product may be shorter than packaging indicates

Details from the source

Reason for recall: The product may be shorter than packaging indicates Distribution: Worldwide distribution - US Nationwide and the countries of UK, France, Germany, Italy, Netherlands, Chile, Japan, and China. Quantity: 129 units Lot/code info: UDI/DI 00843576100268: REF 28-M4-22-190-22S, Lot Numbers: B210925203 UDI/DI 00843576149731, REF 28-M4-24-150-24U, Lot Numbers: 2204210015, 2208250004, 2208250003; UDI/DI 00843576149618, REF 28-M4-26-095-26U, Lot Numbers: 2112210189; UDI/DI 00843576149748, REF 28-M4-26-155-26U, Lot Numbers: 2208240053, 2208250164, 2208220204; UDI/DI 00843576100039, REF 28-M4-28-095-28S, Lot Numbers: B220211367, B220129307, B220211163; UDI/DI 00843576149625, REF 28-M4-28-095-28U, Lot Numbers: 2208220081; UDI/DI 00843576150119, REF 28-M4-28-155-24U, Lot Numbers: 2210110060, 2202150279, 2202150279; UDI/DI 00843576100169, REF 28-M4-28-155-28S, Lot Numbers: B220209262; UDI/DI 00843576149755, REF 28-M4-28-155-28U, Lot Numbers: 2208240183; UDI/DI 00843576150218, REF 28-M4-28-195-24U, Lot Numbers: 2202030119; UDI/DI 00843576149885, REF 28-M4-28-195-28U, Lot Numbers: 2109150299; UDI/DI 00843576150317, REF 28-M4-28-250-24U, Lot Numbers: 2202100029; UDI/DI 00843576150010, REF 28-M4-28-250-28U, Lot Numbers: 2202010127; UDI/DI 00843576100046, REF 28-M4-30-095-30S, Lot Numbers: B220228338; UDI/DI 00843576149632, REF 28-M4-30-095-30U, Lot Numbers: 2208240127, 2112140029, 2202070140; UDI/DI 00843576150126, REF 28-M4-30-155-26U, Lot Numbers: 2203080218; UDI/DI 00843576100176, REF 28-M4-30-155-30S, Lot Numbers: B220825157, B211229047, B220211164, B211228037; UDI/DI 00843576149762, REF 28-M4-30-155-30U, Lot Numbers: 2202100215, 2208240129; UDI/DI 00843576100633, REF 28-M4-30-200-26S, Lot Numbers: B220207438; UDI

UPC codes

00843576100268, 00843576149731, 00843576149618, 00843576149748, 00843576100039, 00843576149625, 00843576150119, 00843576100169, 00843576149755, 00843576150218, 00843576149885, 00843576150317, 00843576150010, 00843576100046, 00843576149632, 00843576150126, 00843576100176, 00843576149762, 00843576100633, 00843576100305, 00843576100732, 00843576150027, 00843576100053, 00843576100541, 00843576100183, 00843576149779, 00843576100640, 00843576100749, 00843576150331, 00843576150034, 00843576149656, 00843576100558, 00843576150140, 00843576100190, 00843576149786, 00843576100657, 00843576150249, 00843576100329, 00843576149915, 00843576100756

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.